Although the symptomatic and epithelial (histologic and endoscopic) response to antireflux therapy are well known and extensively studied, little is known of the genetic events occurring in response to proton pump inhibitor therapy. Preliminary data from our laboratory has shown, for example, that COX-2 expression is not only elevated in patients with gastroesophageal reflux disease but also can be correlated with pathologic esophageal acid exposure on 24 hour pH monitoring. Similar studies have suggested that antireflux surgery may normalize COX-2 gene expression. In contrast studies following ablation of dysplastic Barrett's epithelium have shown persistence of genetic changes associated with altered cellular function, despite the return of the histologic appearance to normal. Several key mediators of inflammation, metaplasia (Barrett's) and neoplasia have now been well characterized and shown to be important factors in the pathogenesis of esophageal injury. It is likely that successful antireflux therapy returns altered expression of these mediators toward normal although this hypothesis remains largely unexplored. The aim of this study is to investigate gene expression of key mediators of the spectrum of esophageal mucosal injury and the response to antireflux therapy.

Hypothesis: Antireflux therapy (proton pump inhibitor and surgical fundoplication) normalizes the expression of genes known to be involved in the pathogenesis of inflammation (esophagitis), metaplasia (Barrett esophagus) and neoplasia (adenocarcinoma).

Patients using medications that may interfere with gene expression (Immunosuppressants, Aspirin, NSAIDs, Corticosteroids).

Patients with diseases that may interfere with gene expression (autoimmune diseases, diseases that course with immunosuppression).

Contacts and Locations

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Please refer to this study by its ClinicalTrials.gov identifier: NCT00624546

Locations

United States, New York

Strong Memorial Hospital

Rochester, New York, United States, 14564

Sponsors and Collaborators

University of Rochester

Takeda Pharmaceuticals North America, Inc.

Investigators

Principal Investigator:

Jeffrey H Peters

University of Rochester

More Information

No publications provided

Responsible Party:

Jeffrey H Peters, Professor and Chair of the Department of Surgery, University of Rochester